EUCTR2014-001546-25-NL进行中(未招募)1 期
Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial
VU University Medical Center0 个研究点目标入组 240 人开始时间: 2014年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
- •2.High-risk neutropenia;
- •4.Age 18 years or older;
- •5.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
- •2.Corticosteroid use =10 mg per day prednisolone or equivalent for more than 3 consecutive days during the previous 7 days.
- •3.Clinically or microbiologically documented infection.
- •4.Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
- •5.Previous enrollment in this study during the same episode of neutropenia.
- •6.Any critical illness for which Intensive Care Unit treatment is required.
- •7.Legal incompetency
研究者
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